BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 21463917 · Received February 25, 2025

    Report

    Report Number
    2916596-2025-01048
    Event Type
    Death
    Date Received
    February 25, 2025
    Date of Event
    November 30, 2021
    Report Date
    March 12, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A, D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B2: DATE OF DEATH WAS NOT PROVIDED SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE SINCE DATE OF DATA COLLECTION WAS NOT PROVIDED. ARTICLE TITLE: ASSOCIATION BETWEEN CASELOAD VOLUME AND OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE IMPLANTATIONS¿ A EUROMACS ANALYSIS. MIHALJ, M., REINEKE, D., JUST, I. A., MULZER, J., CHOLEVAS, N., HOERMANDINGER, C., VEEN, K., LUEDI, M. M., HEINISCH, P. P., POTAPOV, E., GUMMERT, J. F., MOHACSI, P., HAGL, C., FAERBER, G., ZIMPFER, D., DE BY, T. M., MEYNS, B., GUSTAFSSON, F., HUNZIKER, L., . . . SCHOENRATH, F. (2024). ASSOCIATION BETWEEN CASELOAD VOLUME AND OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE IMPLANTATIONS ¿ A EUROMACS ANALYSIS. EUROPEAN JOURNAL OF HEART FAILURE, 26(11), 2400¿2409. HTTPS://DOI.ORG/10.1002/EJHF.3418. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D1: BRAND NAME CORRECTED. SECTION D4: MODEL NUMBER AND CATALOG NUMBER CORRECTED. SECTION E: REPORTER INFORMATION CORRECTED. SECTION G2: REPORT SOURCE CORRECTED. SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS 30NOV2021 AS DATA WAS COLLECTED UNTIL 30NOV2021. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEMS (LVAS) AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SERIAL NUMBERS OF THE HEARTMATE 3 LEFT VENTRICULAR SYSTEMS IN USE WERE NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REVISION D, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "ASSOCIATION BETWEEN CASELOAD VOLUME AND OUTCOMES IN LEFT VENTRICULAR ASSIST DEVICE IMPLANTATIONS¿ A EUROMACS ANALYSIS" THAT HEARTMATE 3 PATIENTS MAY HAVE EXPERIENCED MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS, RIGHT HEART FAILURE, GASTROINTESTINAL BLEEDING, DRIVELINE INFECTION, PUMP THROMBOSIS, MAJOR DEVICE MALFUNCTION EXCLUDING PUMP THROMBOSIS, MAJOR NEUROLOGICAL DYSFUNCTION, MAJOR BLEEDING, READMISSION, OUTFLOW GRAFT OBSTRUCTION, MAJOR DEVICE INFECTION EXCLUDING DRIVELINE, DEVICE EXCHANGE, TRANSPLANT AND DEATH. THIS IS AN OBSERVATIONAL EUROPE-WIDE RETROSPECTIVE ANALYSIS OF ALL PRIMARY CONTINUOUS-FLOW LVAD IMPLANTATIONS RECORDED IN THE EUROPEAN REGISTRY FOR PATIENTS WITH MECHANICAL CIRCULATORY SUPPORT (EUROMACS) REGISTRY BETWEEN 1 JANUARY 2011 AND 31 DECEMBER 2020, WITH CENSOR DATE 30 NOVEMBER 2021. THE EUROMACS REGISTRY INCLUDES 52 CENTRES FROM 18 EUROPEAN COUNTRIES AND OVER 5000 PATIENTS ON LVAD SUPPORT. THE STUDY AIMED TO INVESTIGATE THE ASSOCIATION BETWEEN THE ANNUAL AND CUMULATIVE CASELOAD AND CLINICAL OUTCOMES IN LVAD PATIENTS IN EUROPE. PATIENTS WERE FOLLOWED UP FROM THE TIME OF DEVICE IMPLANT UNTIL DEATH, HEART TRANSPLANTATION, DEVICE EXPLANT, RECOVERY, LOSS TO FOLLOW-UP, OR CENSOR DATE, WHICHEVER OCCURRED FIRST. THE PRIMARY ENDPOINT WAS DEFINED AS 1-YEAR OVERALL SURVIVAL. SECONDARY OUTCOMES INCLUDED SURVIVAL AT 90 DAYS AND 3 YEARS, AS WELL AS DEVICE-RELATED ADVERSE EVENTS (DISABLING STROKE, MAJOR DEVICE INFECTION [EXCLUDING DRIVELINE], PUMP THROMBOSIS OR OUTFLOW GRAFT OBSTRUCTION, MAJOR BLEEDING, RIGHT HEART FAILURE), UNPLANNED REHOSPITALIZATION, AND EVENT-FREE-SURVIVAL. COMPETING RISK ANALYSIS WAS USED FOR SURVIVAL AND DEVICE EXPLANT DUE TO DEVICE EXCHANGE, HEART TRANSPLANTATION, OR MYOCARDIAL RECOVERY. A SUBGROUP ANALYSIS CONSIDERED ONLY PATIENTS SUPPORTED WITH HM3 DEVICES. A TOTAL OF 4802 PATIENTS UNDERWENT PRIMARY LVAD IMPLANTATION IN 35 PARTICIPATING CENTRES, 1522 OF THOSE PATIENTS WERE IMPLANTED WITH HEARTMATE 3. CUMULATIVE FOLLOW-UP AMOUNTED TO 10003 PATIENT-YEARS, WITH A MEDIAN FOLLOW-UP OF 1.54 YEARS (INTERQUARTILE RANGE [IQR] 0.52¿3.15). MEDIAN AGE WAS 57.0 YEARS (IQR 48.0¿63.0), AND THE MAJORITY WERE MALE (82.9%). IN TOTAL, 2147 (44.7%) PATIENTS DIED, AFTER MEDIAN 286 DAYS OF SUPPORT (IQR 48¿860). WHEN CONSIDERING INDIVIDUAL ADVERSE EVENTS, HIGHER ANNUAL CASELOAD CENTRES DOCUMENTED ELEVATED INCIDENCE OF AND RISK FOR PUMP THROMBOSIS OR OUTFLOW GRAFT OBSTRUCTION AS FIRST EVENT (ASHR 1.76, 95%CI 1.18¿2.62, P=0.005), AS WELL AS A RECURRENT EVENT (P<0.001). CENTRES WITH HIGHER ANNUAL CASELOADS ALSO NOTED A REDUCED RISK FOR MAJOR DEVICE MALFUNCTIONS OTHER THAN PUMP THROMBOSIS (SHR 0.50, 95% CI 0.27¿0.90, P=0.022), AS WELL AS REDUCED RISK OF DISABLING STROKE (ASHR0.42, 95%CI 0.20¿0.87, P=0.019). IN THE SUBGROUP ANALYSIS INCLUDING HM3 PATIENTS ONLY, FIRST EVENTS OBSERVED A SIGNIFICANTLY ELEVATED 5.2-FOLD RISK INCREASE FOR PUMP THROMBOSIS OR OUTFLOW GRAFT OBSTRUCTION (P=0.007)IN HIGHER CASELOAD CENTRES, AS WELL AS INCREASED RISKS FOR INITIAL DRIVELINE INFECTIONS AND INITIAL MAJOR BLEEDING EVENTS (ASHR 2.36,P0.005; AND A SHR 1.79, P=0.049, RESPECTIVELY). FIRST EVENTS EXPERIENCED BY HM3 PATIENTS ALSO INCLUDED MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS, RIGHT HEART FAILURE, GASTROINTESTINAL BLEEDING, DRIVELINE INFECTION, PUMP THROMBOSIS, MAJOR DEVICE MALFUNCTION EXCLUDING PUMP THROMBOSIS, MAJOR NEUROLOGICAL DYSFUNCTION, MAJOR BLEEDING, AND READMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367340 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death